The STERRAD™ Chemical Indicator (CI) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:

· STERRAD™ 100S Sterilization System
· STERRAD NXTM Sterilization System
o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
· STERRAD™ 100NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology o ULTRA GITM Cycle with Integrated ALLClear Technology

STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 11140-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems:
· STERRAD™ 100S Sterilization System
· STERRAD NXTM Sterilization System
o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology

· STERRAD™ 100NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology o ULTRA GI™ Cycle with Integrated ALLClear™ Technology
The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed loads.

The STERRAD VELOCITY™ Biological Indicator (BI)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems:

. STERRAD™ 100NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
o ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only).
. STERRAD NX™ Sterilization System
o (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology
· STERRAD™ 100S Sterilization System

The ULTRA GI™ Process Challenge Device (PCD) Vial is used with the STERRAD VELOCITY™ Biological Indicator (BI) for periodic testing and frequent monitoring of the ULTRA GI™ Cycle in the STERRAD™ 100NX Sterilization System with ALLClear™ Technology.

Device Description

The STERRAD™ Chemical Indicator (Cl) Strip consists of chemically reactive ink, a clear overcoat ink, a yellow comparator bar, and black ink for copy printed on a strip of white styrene. This device is a through-put process indicator to be used with ASP's STERRAD™ Sterilization Systems. The STERRAD Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. When in the presence of hydrogen peroxide, the indicator will change from red to yellow as indicated by the comparator bar to indicate that the load has been exposed to hydrogen peroxide.

The STERRAD™ SEALSURE™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD™ Sterilization Systems that utilize hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. The Chemical Indicator Tape reacts with hydrogen peroxide as it is introduced into the sterilization chamber. The chemical reaction between the indicator ink and the hydrogen peroxide causes the dye of the indicator ink on the diagonal STERRAD logos and the chemical indicator square on the tape to change color, indicating that the load has been exposed to hydrogen peroxide.

The STERRAD VELOCITY Biological Indicator (BI) is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and/or periodic testing in STERRAD Sterilization Systems.

The assembled ULTRA GI PCD is composed of a vial that encapsulates the STERRAD VELOCITY Biological Indicator (BI). The vial creates a stronger resistance to the ULTRA GI Cycle. At the end of the Bl is removed from the vial and used in conjunction with the STERRAD VELOCITY Reader (software version 1139260417 or newer) to verify the effectiveness of the ULTRA GI PCD Vial is only used for the ULTRA GI Cycle in STERRAD 100NX Sterilizers.

AI/ML Overview

The provided document describes the acceptance criteria and the studies conducted for several sterilization process indicators and related devices (Chemical Indicator Strip, Chemical Indicator Tape, Biological Indicator, Biological Indicator Reader, and Process Challenge Device Vial). The studies aim to demonstrate the substantial equivalence of these devices to their legally marketed predicates, particularly with the inclusion of the new ULTRA GI Cycle.

Here's a breakdown of the requested information for each device where available:

1. STERRAD™ Chemical Indicator (CI) Strip (14100)

1. Table of acceptance criteria and reported device performance:

Performance Testing	Acceptance Criteria	Reported Device Performance
Chemical Indicator Functionality	The Chemical Indicator will not change color when not exposed to the cycle parameter indication. The Chemical Indicator will change color when exposed to cycle parameter indication.	Pass
Residual Biocompatibility	The residual hydrogen peroxide level shall be below the LOQ and exhibit mild toxicity or lower.	Pass
End Point / Post Processing Color Stability	The chemical indicator shall perform to the Type 1 requirements of ISO 11140-1:2014.	Pass

2. Sample size used for the test set and data provenance:

Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and qualifications:

Not applicable for these types of physical/chemical indicators. Ground truth is based on physical/chemical properties and adherence to ISO standards.

4. Adjudication method for the test set:

Not applicable. Performance is based on objective chemical reactions and physical changes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This is not applicable for chemical indicators.

6. If a standalone study (algorithm only without human-in-the-loop performance) was done:

Yes, the studies described are standalone performance tests of the chemical indicator strip itself.

7. Type of ground truth used:

Objective physical/chemical change (color change due to hydrogen peroxide exposure) validated against ISO 11140-1:2014 Type 1 requirements.

8. Sample size for the training set:

Not applicable. These are physical/chemical indicators, not AI/ML devices with training sets.

9. How the ground truth for the training set was established:

Not applicable.

2. STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape (14202NL)

1. Table of acceptance criteria and reported device performance:

Performance Testing	Acceptance Criteria	Reported Device Performance
Chemical Indicator Functionality	The Chemical Indicator will not change color when not exposed to the cycle parameter indication. The Chemical Indicator will change color when exposed to cycle parameter indication.	Pass
Residual Biocompatibility	The residual hydrogen peroxide level shall be below the LOQ and exhibit mild toxicity or lower.	Pass
End Point / Post Processing Color Stability	The chemical indicator shall perform to the Type 1 requirements of ISO 11140-1:2014.	Pass
Tape Adhesion Strength	The peel strength (adhesion-strength) must meet the acceptance criteria.	Pass

2. Sample size used for the test set and data provenance:

Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and qualifications:

Not applicable for these types of physical/chemical indicators. Ground truth is based on physical/chemical properties and adherence to ISO standards.

4. Adjudication method for the test set:

Not applicable. Performance is based on objective chemical reactions and physical changes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This is not applicable for chemical indicators.

6. If a standalone study (algorithm only without human-in-the-loop performance) was done:

Yes, the studies described are standalone performance tests of the chemical indicator tape itself.

7. Type of ground truth used:

Objective physical/chemical change (color change due to hydrogen peroxide exposure) and physical properties (adhesion strength) validated against ISO 11140-1:2014 Type 1 requirements.

8. Sample size for the training set:

Not applicable. These are physical/chemical indicators, not AI/ML devices with training sets.

9. How the ground truth for the training set was established:

Not applicable.

3. STERRAD VELOCITY™ Biological Indicator (BI) and STERRAD VELOCITY™ Reader (43210, 43210-30, 43220)

1. Table of acceptance criteria and reported device performance:

Performance Testing	Acceptance Criteria	Reported Device Performance
Biological Indicator Performance	General trend of increasing number of sterile BIs (growth and fluorescence) with increasing hydrogen peroxide injection volume. All BIs negative for fluorescence and growth at full cycle.	Pass
Verification of Growth Inhibition of the Biological Indicator	All test samples (positive controls) show growth. All negative controls show no growth.	Pass
Chemical Indicator Functionality of Biological Indicator	Chemical Indicator will not change color when not exposed to the cycle parameter indication. Chemical Indicator will change color when exposed to cycle parameter indication.	Pass
Fluorescence Performance of Biological Indicator	BI fluorescence-positive for greater than 97.0% of all growth-positive BIs.	Pass

2. Sample size used for the test set and data provenance:

Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and qualifications:

Not applicable. Ground truth for biological indicators is based on microbiological growth/no growth and fluorescence detection, which are objective measures.

4. Adjudication method for the test set:

Not applicable. Performance is based on objective microbiological and fluorescence readings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This is not applicable for biological indicators and their readers.

6. If a standalone study (algorithm only without human-in-the-loop performance) was done:

Yes, the studies described are for the standalone performance of the biological indicator and the reader. The reader's "algorithm" interprets the fluorescence, but it's not described as an AI/ML system requiring typical training/test sets.

7. Type of ground truth used:

Microbiological growth (absence or presence of Geobacillus stearothermophilus ATCC 7953) and fluorescence detection, which correlates to enzymatic activity of the organism.

8. Sample size for the training set:

Not applicable. While the reader processes data, it's not described as an AI/ML system with a separate training set.

9. How the ground truth for the training set was established:

Not applicable.

4. ULTRA GI™ Process Challenge Device (PCD) Vial (43400)

1. Table of acceptance criteria and reported device performance:

Performance Testing	Acceptance Criteria	Reported Device Performance
Hydrogen Peroxide Dose-Response and Sterilization Verification	The general trend is an increasing number of sterile BIs (growth and fluorescence) with increasing hydrogen peroxide injection volume. All BIs are negative for fluorescence and growth at full cycle.	Pass
Performance Qualification	The STERRAD VELOCITY BI/PCD fluorescence readout is qualified for performance in frequent monitoring and periodic testing indication.	Pass

2. Sample size used for the test set and data provenance:

Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and qualifications:

Not applicable. Ground truth for PCDs is based on the resistance they provide to the sterilization process, measured using biological indicator growth/no growth and fluorescence detection.

4. Adjudication method for the test set:

Not applicable. Performance is based on objective microbiological and fluorescence readings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This is not applicable for PCDs.

6. If a standalone study (algorithm only without human-in-the-loop performance) was done:

Yes, the studies described are for the standalone performance of the PCD vial in conjunction with the biological indicator and reader.

7. Type of ground truth used:

Microbiological growth (absence or presence of Geobacillus stearothermophilus) and fluorescence detection, demonstrating the designed resistance to the sterilization process.

8. Sample size for the training set:

Not applicable.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

July 5, 2024

Advanced Sterilization Products, Inc. Brandon Roberts Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618

Re: K234084

Trade/Device Name: STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (60 count) (43210); STERRAD VELOCITY™ Biological Indicator (BI) (30 count) (43210-30): STERRAD VELOCITY™ Reader (43220): ULTRA GITM Process Challenge Device (PCD) Vial (30 count) (43400) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ, FRC Dated: December 22, 2023 Received: June 7, 2024

Dear Brandon Roberts:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

{2}------------------------------------------------

Sincerely, Christopher K. Dugard -2

Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known) K234084

Device Name

STERRAD™ Chemical Indicator (CI) Strip (14100)

Indications for Use (Describe)

· STERRAD™ 100S Sterilization System
· STERRAD NXTM Sterilization System

o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology

· STERRAD™ 100NX Sterilization System
- o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology o ULTRA GITM Cycle with Integrated ALLClear Technology

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{4}------------------------------------------------

510(k) Number (if known) K234084

Device Name

STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape (14202NL)

Indications for Use (Describe)

· STERRAD™ 100S Sterilization System

· STERRAD NXTM Sterilization System

o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology

· STERRAD™ 100NX Sterilization System
o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology o ULTRA GI™ Cycle with Integrated ALLClear™ Technology

The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed loads.

Type of Use (Select one or both, as applicable)

Residential Use (Per 24 CFR 982.305) Primary Residence	Rent To Owner (Per 24 CFR 982.305) Primary Residence
---------------------------------------------------------------------------------	------------------------------------------------------------------------------------------

| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{5}------------------------------------------------

510(k) Number (if known) K234084

Device Name

STERRAD VELOCITY™ Biological Indicator (BI) (60 count) (43210); STERRAD VELOCITY™ Biological Indicator (BI) (30 count) (43210-30); STERRAD VELOCITY™ Reader (43220)

Indications for Use (Describe)

· STERRAD™ 100NX Sterilization System

o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology

o ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only).

· STERRAD NXTM Sterilization System
o (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology

· STERRAD™ 100S Sterilization System

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{6}------------------------------------------------

510(k) Number (if known) K234084

Device Name

ULTRA GITM Process Challenge Device (PCD) Vial (43400) (30 count)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{7}------------------------------------------------

510(k) Summary for K234084 Advanced Sterilization Products, Inc. STERRAD™ Chemical Indicator (CI) Strip

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

General Information

Submitter Name:	Advanced Sterilization Products, Inc.
Address:	33 Technology Drive
	Irvine, CA 92618
Contact Person:	Brandon Roberts
	Senior Regulatory Affairs Specialist
	Phone: (323) 590-4214
	Email: brandon.roberts@asp.com
Date Prepared:	July 2, 2024
Device Name
Proprietary Name:	STERRAD™ Chemical Indicator (CI) Strip (14100)
Common Name:	Chemical Sterilization Process Indicator Strip
Classification Name:	Indicator, Physical/Chemical Sterilization Process
Device Class:	Class II
Product Code:	JOJ
CFR Section:	21 CFR 880.2800

Predicate Device

STERRAD® Chemical Indicator Strip cleared under 510(k) K111518 on October 3, 2012.

{8}------------------------------------------------

Device Description

The STERRAD Chemical Indicator (CI) Strip does not imply that sterilization has been achieved or to assure that the sterilization cycle has been completed. Rather, it provides a visual indication that hydrogen peroxide, an essential ingredient in the operation of the STERRAD System sterilization process, is present in the sterilization chamber.

Intended Use/Indications For Use

The STERRAD™ Chemical Indicator (Cl) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:

. STERRAD™ 100S Sterilization System
. STERRAD NX™ Sterilization System
- STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology o
. STERRAD™ 100NX Sterilization System
- o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology
- ULTRA GI™ Cycle with Integrated ALLClear Technology o

Device Characteristics	Subject Device	Predicate Device
	STERRAD™ Chemical IndicatorStrip (K234084)	STERRAD® Chemical IndicatorStrip (K111518)
Intended Use	The STERRAD™ ChemicalIndicator (CI) Strip is a processindicator that is intended todifferentiate processed fromunprocessed packages and isintended for use with medicaldevice packages to besterilized in STERRAD™Sterilization Systems.	Same
Indications for Use	The STERRAD™ ChemicalIndicator (CI) Strip is a processindicator per ISO 11140-1:2014[Type ] (to differentiateprocessed from unprocessed	The STERRAD® ChemicalIndicator Strip (PN 14100) is aprocess indicator (ISO 11140-1:2005) to differentiateprocessed from unprocessed

Comparison of Technological Characteristics

{9}------------------------------------------------

Device Characteristics	Subject Device	Predicate Device
	STERRAD™ Chemical IndicatorStrip (K234084)packages) and is intended foruse with medical devicepackages to be sterilized in thefollowing STERRAD™Sterilization Systems:STERRAD™ 100SSterilization System STERRAD NX™Sterilization System STANDARD ANDADVANCEDCycles with andwithoutALLClear™Technology STERRAD™ 100NXSterilization System STANDARD,FLEX, EXPRESS,and DUO Cycleswith andwithoutALLClearTechnology ULTRA GI™Cycle withIntegratedALLClearTechnology	STERRAD® Chemical IndicatorStrip (K111518)packages and is intended foruse with medical devicepackages to be sterilized inSTERRAD® SterilizationSystems:MODEL CYCLE STERRAD®100S Standard STERRAD®50 Standard STERRAD®200 Standard STERRAD®NX® StandardAdvanced STERRAD®100NX® StandardFlexExpressDUO
Contraindications	None	Same
Precautions	1. Do not use after theexpiration date.2. STERRAD CI Strip is notindicated for use withsteam or ethylene oxidesterilization cycles.3. If the indicator bar hasnot completely changedfrom red to yellow (orlighter) indicated by thecomparator bar,	Same

{10}------------------------------------------------

Device Characteristics	Subject Device	Predicate Device
	STERRAD™ Chemical IndicatorStrip (K234084)	STERRAD® Chemical IndicatorStrip (K111518)
	introduction of hydrogenperoxide, an essentialcomponent of theSTERRAD SterilizationCycle, may not havetaken place.4. Single use only. Do notreuse as the ChemicalIndicator Strip will notfunction as intended ifreused.
Regulation/Product Code	880.2800 /JOJ	Same
Technology	Through-put process indicator	Same
Device Design: Functionality	Strip with Chemical Indicator	Same
Device Design: ChemicalReaction	N-Oxidation of tertiary amine inthe presence of hydrogenperoxide.	Same
Device Design: Cycle ParameterIndication	Hydrogen Peroxide	Same
Device Design	Indicator bar changes from redto yellow (or lighter) asindicated by comparator barwhen exposed tohydrogen peroxide.	Same
Distinct Color Change	Red (pre-processed) to yellowor lighter (post-processed) asindicated by comparator bar.	Same
Endpoint Color	Yellow or lighter as indicatedby comparator bar (PantoneColor Formula Guide 144C).	Same
Single Use	Yes	Same
Over the Counter Use Device	Yes	Same
Packaging	Four cartons per shipper boxwith each carton consisted of250 strips placed in apolyethylene bag.	Same

{11}------------------------------------------------

Performance Testing	Description	Acceptance Criteria	Pass/Fail
Chemical IndicatorFunctionality	This study verified theChemical Indicatorfunctionality afterprocessing in the ULTRAGI Cycle.	The Chemical Indicatorwill not change colorwhen not exposed tothe cycle parameterindication.The Chemical Indicatorwill change color whenexposed to cycleparameter indication.	Pass
ResidualBiocompatibility	This studydemonstrated thebiocompatibility of theChemical Indicator postprocessing in the ULTRAGI Cycle.	The residual hydrogenperoxide level shall bebelow the LOQ andexhibit mild toxicity orlower.	Pass
End Point /PostProcessing ColorStability	This studydemonstrated that theChemical Indicator willperform to the Type 1requirements of ISO11140-1:2014.	The chemical indicatorshall perform to theType 1 requirements ofISO 11140-1:2014.	Pass

Summary of Non-Clinical Testing

Summary

The subject device, STERRAD Chemical Indicator (CI) Strip (14100), and its predicate utilize the same technology and verification/validation methods to achieve its intended use. The performance testing results indicate that including the ULTRA GI Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject device to be as safe and effective as the predicate.

Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the existing legally marketed predicate device, K111518.

{12}------------------------------------------------

510(k) Summary for K234084 Advanced Sterilization Products, Inc. STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

General Information

Submitter Name:	Advanced Sterilization Products, Inc.
Address:	33 Technology DriveIrvine, CA 92618
Contact Person:	Brandon RobertsSenior Regulatory Affairs SpecialistPhone: (323) 590-4214Email: brandon.roberts@asp.com
Date Prepared:	July 2, 2024
Device Name
Proprietary Name:	STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape(14202NL)
Common Name:	Chemical Sterilization Process Indicator Tape
Classification Name:	Indicator, Physical/Chemical Sterilization Process
Device Class:	Class II
Product Code:	JOJ
CFR Section:	21 CFR 880.2800

Predicate Device

STERRAD® SEALSURE® Chemical Indicator Tape cleared under 510(k) K111519 on October 3, 2012.

{13}------------------------------------------------

Device Description

The Chemical Indicator Tape reacts with hydrogen peroxide as it is introduced into the sterilization chamber. The chemical reaction between the indicator ink and the hydrogen peroxide causes the dye of the indicator ink on the diagonal STERRAD logos and the chemical indicator square on the tape to change color, indicating that the load has been exposed to hydrogen peroxide.

STERRAD SEALSURE Chemical Indicator Tape does not imply that sterilization has been achieved or to assure that the sterilization cycle has been completed.

Intended Use/Indications For Use

STERRAD™ 100S .
STERRAD NX™ .
- STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
. STERRAD™ 100NX
- STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
- ം

DeviceCharacteristics	Subject Device	Predicate Device
	STERRAD™ SEALSURE™ ChemicalIndicator (CI) Tape (K234084)	STERRAD® SEALSURE® ChemicalIndicator Tape (K111519)
Intended Use	STERRAD SEALSURE ChemicalIndicator (CI) Tape is a processindicator intended for use byhealthcare providers to secure non-woven sterilization packs and wraps tobe sterilized in the STERRADSterilization Systems.	Same

Comparison of Technological Characteristics

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DeviceCharacteristics	Subject Device	Predicate Device
Indications forUse	STERRAD™ SEALSURE™ ChemicalIndicator (CI) Tape (K234084)STERRAD™ SEALSURE™ ChemicalIndicator Tape is a process indicator(ISO 11140-1:2014 [Type 1]) intendedfor use by health care providers tosecure non-woven sterilization packsand wraps to be sterilized in theSTERRAD™ Sterilization Systems:STERRAD™ 100S STERRAD NX™ STANDARD ANDADVANCED Cycles withand without ALLClear™Technology STERRAD™ 100NX STANDARD, FLEX,EXPRESS, and DUOCycles with andwithout ALLClear™Technology ULTRA GI™ Cycle withIntegrated ALLClear™Technology The color of the STERRAD SEALSUREChemical Indicator Tape changesfrom red to gold (or lighter) indicatedby comparator bar when exposed tohydrogen peroxide and is intended todifferentiate between processed andunprocessed loads.	STERRAD® SEALSURE® ChemicalIndicator Tape (K111519)STERRAD® SEALSURE® ChemicalIndicator Tape (PN 14202) is a processindicator (ISO 11140-1:2005) intendedfor use by healthcare providers tosecure non-woven sterilization packsand wraps to be sterilized in theSTERRAD® Sterilization Systems.MODELCYCLE STERRAD®100SStandard STERRAD®50Standard STERRAD®200Standard STERRAD®NXStandardAdvanced STERRAD®100NXStandardFlexExpressDUO The color of the STERRAD® SEALSURE®Chemical Indicator Tape changes fromred to gold (or lighter) when exposedto hydrogen peroxide and is intendedto differentiate between processed andunprocessed loads.
Precaution	None	This product contains dry naturalrubber.
Type of ChemicalIndicator	Through-put process indicator	Same

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Device	Subject Device	Predicate Device
Characteristics	STERRAD™ SEALSURE™ ChemicalIndicator (CI) Tape (K234084)	STERRAD® SEALSURE® ChemicalIndicator Tape (K111519)
ChemicalReaction	Oxidation-reduction reactionspecifically designed to react in thepresence of hydrogen peroxide. Thereaction is not reversible.	Same
Packaging	Six individually wrapped rolls pershipper box.	Same
Design	STERRAD System logo / CI squarechanges from red to gold (or lighter)upon exposure to the sterilant,hydrogen peroxide.	Same
Distinct ColorChange	Red (pre-processed) to gold or lighter(post-processed)	Same
Single Use Device	Yes	Same

Summary of Non-Clinical Testing

Performance Testing	Description	Acceptance Criteria	Pass/Fail
Chemical IndicatorFunctionality	This study verified theChemical Indicatorfunctionality afterprocessing in the ULTRAGI Cycle.	The Chemical Indicatorwill not change colorwhen not exposed tothe cycle parameterindication.The Chemical Indicatorwill change color whenexposed to cycleparameter indication.	Pass
ResidualBiocompatibility	This studydemonstrated thebiocompatibility of theChemical Indicator postprocessing in the ULTRAGI Cycle.	The residual hydrogenperoxide level shall bebelow the LOQ andexhibit mild toxicity orlower.	Pass
End Point /PostProcessing ColorStability	This studydemonstrated that theChemical Indicatorperform to the Type 1	The chemical indicatorshall perform to theType 1 requirements ofISO 11140-1:2014.	Pass

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	requirements of ISO11140-1:2014.

Tape Adhesion Strength	This study verifies theadhesive strength afterprocessing in the ULTRAGI Cycle.	The peel strength(adhesion-strength)must meet theacceptance criteria.	Pass

Summary

The subject device, STERRAD SEALSURE Chemical Indicator (Cl) Tape (14202NL), and its predicate utilize the same technology and verification/validation methods to achieve the intended use. The performance testing results indicate that including the ULTRA GI Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject device to be as safe and effective as the predicate.

Conclusion

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510(k) Summary for K234084 Advanced Sterilization Products, Inc. STERRAD VELOCITY™ Biological Indicator (BI) and STERRAD VELOCITY™ Reader

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

General Information
Submitter Name:	Advanced Sterilization Products, Inc.
Address:	33 Technology DriveIrvine, CA 92618
Contact Person:	Brandon RobertsSenior Regulatory Affairs SpecialistPhone: (323) 590-4214Email: brandon.roberts@asp.com
Date Prepared:	July 2, 2024
Device Name
Proprietary Name:	STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count), STERRADVELOCITY™ Biological Indicator (BI) (43210-30) (30 count) and STERRADVELOCITY™ Reader (43220)
Common Name:	Biological Indicator
Classification Name:	Indicator, Biological Sterilization Process
Device Class:	Class II
Product Code:	FRC
CFR Section:	21 CFR 880.2800

Predicate Device

STERRAD VELOCITY® Biological Indicator/Process Challenge Device (BI/PCD) and STERRAD VELOCITY® Reader cleared under 510(k) K192025 on January 23, 2020.

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Device Description

Intended Use/Indications For Use

. STERRAD™ 100NX Sterilization System
- STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
- ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only). o
. STERRAD NX™ Sterilization System
- (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology
. STERRAD™ 100S Sterilization System

DeviceCharacteristics	Subject Device	Predicate Device
Intended Use	STERRAD VELOCITY™ BI and STERRADVELOCITY™ Reader (K234084)	STERRAD VELOCITY™ BI/PCD andReader (K192025)
	Monitoring of hydrogen peroxide gasplasma sterilization processes.	Same
Indications for Use	The STERRAD VELOCITY™ BiologicalIndicator (BI)/Process Challenge Device(PCD), in conjunction with the STERRADVELOCITY™ Reader, is intended to beused as a standard method for frequentmonitoring and/or periodic testing ofthe following STERRAD™ Systems:• STERRAD™ 100NX SterilizationSystem• STANDARD, FLEX,EXPRESS, and DUOCycles with and withoutALLClear™ Technology• ULTRA GI™ Cycle withIntegrated ALLClearTechnology (for	STERRAD VELOCITY® BiologicalIndicator/Process Challenge Device, inconjunction with the STERRAD VELOCITYReader, is intended to be used as astandard method for frequentmonitoring and periodic testing of thefollowing STERRAD Sterilization Systems:• STERRAD® IOONX (STANDARD,FLEX, EXPRESS, and DUOCycles) with and withoutALLClear® Technology• STERRAD NX® (STANDARD andADVANCED Cycles) with andwithout ALLClear® Technology• STERRAD 100S
	Subject Device	Predicate Device
DeviceCharacteristics	STERRAD VELOCITY™ BI and STERRADVELOCITY™ Reader (K234084)frequent monitoringonly).• STERRAD NX™ SterilizationSystemo (STANDARD ANDADVANCED Cycles) withand without ALLClear™Technology• STERRAD™ 100S SterilizationSystem	STERRAD VELOCITY™ BI/PCD andReader (K192025)
Organism(Spore, Species,Strain)	Geobacillus stearothermophilusATCC 7953	Same
Viable SporePopulation	$\ge$ 1x106 CFU/BI	Same
Carrier Material	Glass Fiber	Same
Device Design	Self-contained biological indicator.	Same
ResistanceCharacteristics	• Tested at 5 mg/L hydrogen peroxide:D-value 5mg/L: $\ge$ 1 second, using twoD-value methods (Survivor Curve andFraction Negative) per ISO 11138-1.• Equal to or greater than the mostdifficult item routinely processed(biological model).	Same
Rapid ReadoutTechnology	The α-glucosidase enzyme system isgenerated naturally during the growthof Geobacillus stearothermophilus. Theα-glucosidase enzyme in its active stateis detected by measuring thefluorescence produced by the enzymatichydrolysis of a non-fluorescentsubstrate. The resultant fluorescent by-product is detected in the reader. Thefluorescence signal is used to determinea positive or negative result.	Same
IncubationTemperature	57 +/- 2°C	Same
Incubation Time	15-minute fluorescence results read in	Same
	Subject Device	Predicate Device
DeviceCharacteristics	STERRAD VELOCITY™ BI and STERRADVELOCITY™ Reader (K234084)	STERRAD VELOCITY™ BI/PCD andReader (K192025)
	visual pH color change results at 5 to 7days.
Holding Time	Within 2 hours after sterilization cycle	Same
Carrier growthinhibition/mediagrowth promotion	No bacteriostatic effects that inhibit thegrowth of the indicator microorganism	Same
Chemical Indicator	Type 1 process indicator changes colorfrom red/pink to yellow or yellow withsome red/orange/brown dots toindicate exposure to hydrogen peroxide.	Same
Method ofFluorescenceDetection	UV LED, optical filters, with sensing byphotodiode	Same
Indicator ofAdequateSterilization Cycle	"Negative" displayed on LCD Display	Same
Indicators ofPossible SterilizationCycle Failure	"Positive" displayed on LCD Display,Audible Alarm	Same
Incubation Wells	8 incubation/reader wells	Same
Voltage Range	100-240 Volts AC (12 Volt DC conversionfor internal circuitry)	Same
Product Safety	UL/IEC 61010-1	Same
EMC Compliance	FCC Part 15, Subpart B, Class A	Same

Comparison of Technological Characteristics

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Summary of Non-Clinical Testing -Device

Performance Testing	Description	Acceptance Criteria	Pass/Fail
Biological IndicatorPerformance	This study verified theuse of the BiologicalIndicator for use infrequent monitoring ofthe ULTRA GI Cycle.	General trend ofincreasing number ofsterile Bls (growth andfluorescence) withincreasing hydrogenperoxide injectionvolume. All Bls negativefor fluorescence andgrowth at full cycle.	Pass

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Verification of GrowthInhibition of theBiological Indicator	The study demonstratedthat there is noinhibition effect on theSTERRAD VELOCITY BIcarrier and primarypackaging materialsprocessed through theULTRA GI Cycle.	All test samples (positivecontrols) show growth.All negative controlsshow no growth.	Pass
Chemical IndicatorFunctionality ofBiological Indicator	This study verified theChemical Indicatorfunctionality afterprocessing in the ULTRAGI Cycle.	Chemical Indicator willnot change color whennot exposed to the cycleparameter indication.Chemical Indicator willchange color whenexposed to cycleparameter indication.	Pass
FluorescencePerformance ofBiological Indicator	This study verified theaccuracy of theFluorescence resultscompared to growthpositive Bls.	BI fluorescence-positivefor greater than 97.0%of all growth-positiveBls.	Pass

Summary

The subject devices STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count), STERRAD VELOCITY™ Biological Indicator (BI) (43210-30) (30 count) and STERRAD VELOCITY™ Reader (43220), as well as their predicate, utilize the same technology and verification methods to achieve the intended use. The performance testing results indicate that including the ULTRA GI Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject devices to be as safe and effective as the predicate.

Conclusion

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510(k) Summary for K234084 Advanced Sterilization Products, Inc. ULTRA GI™ Process Challenge Device (PCD) Vial

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

General Information

Submitter Name:	Advanced Sterilization Products, Inc.
Address:	33 Technology DriveIrvine, CA 92618
Contact Person:	Brandon RobertsSenior Regulatory Affairs SpecialistPhone: (323) 590-4214Email: brandon.roberts@asp.com
Date Prepared:	July 2, 2024
Device Name
Proprietary Name:	ULTRA GI™ Process Challenge Device (PCD)(43400) (30 count)
Common Name:	Process Challenge Device
Classification Name:	Indicator, Biological Sterilization Process
Device Class:	Class II
Product Code:	FRC
CFR Section:	21 CFR 880.2800

Predicate Device

STERRAD VELOCITY® Biological Indicator/Process Challenge Device and STERRAD VELOCITY® Reader cleared under 510(k) K192025 on January 23, 2020.

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Device Description

Intended Use/Indications For Use

	Subject Device	Predicate Device
DeviceCharacteristics	ULTRA GI™ PROCESS CHALLENGEDEVICE (PCD) Vial (K234084)	STERRAD VELOCITY™ BI/PCD andReader (K192025)
Intended Use	Monitoring of hydrogen peroxide gasplasma sterilization processes whenused in conjunction with the STERRADVELOCITY™ BI.	Same
Indications for Use	The ULTRA GI™ Process ChallengeDevice (PCD) Vial is used with theSTERRAD VELOCITY™ BiologicalIndicator (BI) for periodic testing andfrequent monitoring of the ULTRA GI™Cycle in the STERRAD™ 100NXSterilization System with ALLClear™Technology.	STERRAD VELOCITY® BiologicalIndicator/Process Challenge Device, inconjunction with the STERRAD VELOCITYReader, is intended to be used as astandard method for frequentmonitoring and periodic testing of thefollowing STERRAD Sterilization Systems:STERRAD® 100NX (STANDARD,FLEX, EXPRESS, and DUOCycles) with and withoutALLClear® Technology STERRAD NX® (STANDARD andADVANCED Cycles) with andwithout ALLClear® Technology STERRAD 100S
Vial Material	Polypropylene (vial)Buna-N (O-rings in vial)Polyester+acrylic adhesive (label)	N/A
Device Design	ULTRA GI™ Process Challenge Device(PCD) Vial encapsulates the STERRADVELOCITY™ Biological Indicator (BI).	Self-contained biological indicator.

Comparison of Technological Characteristics

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DeviceCharacteristics	Subject Device	Predicate Device
ResistanceCharacteristics	ULTRA GI™ PROCESS CHALLENGEDEVICE (PCD) Vial (K234084)	STERRAD VELOCITY™ BI/PCD andReader (K192025)
	Tested at 5 mg/L hydrogen peroxide:D-value $_{5mg/L}$ : ≥ 1 second, using twoD-value methods (Survivor Curve andFraction Negative) per ISO 11138-1. Equal to or greater than the mostdifficult item routinely processed(biological model).	Same

Summary of Non-Clinical Testing - Biological Indicator/Process Challenge Device

Performance Testing	Description	Acceptance Criteria	Pass/Fail
Hydrogen PeroxideDose-Response andSterilization Verification	This study verified thedesign of the ULTRA GIPCD fluorescence. The BIreadout in conjunctionwith the PCD vialprovides a greaterresistance incomparison to thebiological model to thesterilization processusing the ULTRA GICycle.	The general trend is anincreasing number ofsterile Bls (growth andfluorescence) withincreasing hydrogenperoxide injectionvolume. All BIs arenegative forfluorescence and growthat full cycle.	Pass
PerformanceQualification	This study verified thefluorescence readperformance when usedfor period testing andfrequent monitoring.	The STERRAD VELOCITYBI/PCD fluorescencereadout is qualified forperformance in frequentmonitoring and periodictesting indication.	Pass

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Summary

The subject device, ULTRA GI Process Challenge Device (PCD) Vial (43400) (30 count), and its predicate utilize the same technology and verification/validation methods to achieve the intended use. The performance testing results indicate that including the ULTRA GI Cycle does not raise any new questions of safety or effectiveness. ASP believes the subject devices to be as safe and effective as the predicate.

Conclusion

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).